Mifepristone After Trauma to Enhance Resilience

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New York,
New York10029

Purpose:

he purpose of this study is to test whether a medication, called mifepristone (commonly
known as the ³Morning-After-Pill²), can help to prevent emotional problems after someone has
survived a traumatic experience. We are studying this medication for the treatment of
Post-traumatic Stress disorder (PTSD.

Study summary:

PTSD is an emotional illness that can develop in people after they have experienced a
traumatic event. It involves symptoms such as poor sleep, nightmares about the trauma,
unwanted daytime memories of the trauma (flashbacks), jumpiness, and trouble looking forward
to things in the future. Once people develop PTSD, the symptoms tend to last a very long
time.
We are testing the idea that mifepristone, which blocks the effect of the hormones
progesterone and cortisol, will help treat PTSD. Progesterone is a hormone made in the
bodies of both men and women and its main role is in regulating the menstrual cycle and in
pregnancy. Cortisol is also a hormone made in the body of both men and women and helps the
body respond to stress. Cortisol also has a role in making emotional memories more intense
than other memories. We are testing whether blocking the effect of cortisol with
mifepristone as you recall your trauma may be able to decrease the intensity of your
traumatic memories. This medication will not completely block out your memories of the
traumatic experience but may decrease how much your thoughts are drawn back to the memory of
the traumatic event.

Criteria:

Inclusion Criteria:
- Male or Female
- Between 18 and 65 years old
- Have experienced one or more traumatic events within the last year €Examples for
traumatic events include physical or sexual assault, combat, natural disasters,
witnessing death or injury of another person, bereavement €Currently experiencing
severe symptoms of anxiety including flashbacks and intrusive memories of the
traumatic event. €Not currently pregnant or intending to become pregnant. If sexually
active, participants must be using an approved form of birth control
- Medically healthy
- Not currently taking psychiatric medications
Exclusion Criteria:
- > Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar
disorder, or current Axis I disorder (except for major depression secondary to the
PTSD)
- Current evidence or history of significant unstable medical illness or organic brain
impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary,
gastrointestinal, or renal or hepatic impairment.
- Patient who in the investigator¹s judgment pose a current suicidal or homicidal risk
- DSM-IV substance abuse or dependence within the past 90 days
- Patient has been taking psychotropic medication in the last 2 weeks (5 weeks for
fluoxetine) prior to screening. Psychotropic medications in the last 2 weeks prior to
screening, fluoxetine in last 5 weeks.
- Treatment with any other concomitant medication with primarily CNS activity
- Treatment with any medication that the PI considers not acceptable for this study.
- Patient regularly, or on average, drinks more than a) 28 units of alcohol per week
for male patients, or b) 21 units of alcohol per week for female patients (1 unit =
1/2 pint of beer, or 1 glass of wine, or 1 measure of spirit)
- Pregnancy or lactation*
- Patient is currently receiving evidenced-based structured psychotherapy (e.g.,
cognitive-behavioral therapy, exposure therapy).

NCT ID:

NCT00554177

Primary Contact:

Principal InvestigatorAntonia New, MDIcahn School of Medicine at Mount Sinai

Backup Contact:

N/A

Location Contact:

New York, New York 10029United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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